DIAZEMULS Emulsion

Product name and form

Diazemuls.

Diazepam Accord 5mg/ml Emulsion for Injection.

Pharmaceutical Form

Sterile, milky white emulsion.

Qualitative and quantitative composition

Each emulsion contains Diazepam 0.5% w/v.

Also contains fractionated soy bean oil. One 1ml of emulsion contains 150mg soya bean oil.

For the full list of excipients, see section 6.1.

List of Excipients

Fractionated soy bean oil
Diacetylated monoglycerides
Fractionated egg phospholipids
Glycerol (anhydrous)
Sodium hydroxide (to pH8)
Water for injections (to 2ml)

Pack sizes and marketing

2ml glass type 1 ampoules in cartons of 10.

Marketing authorization holder

Accord Healthcare Limited, Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom

Marketing authorization dates and numbers

PL 20075/0679

Date of first authorisation: 15th March 1989
Date of latest renewal: 10th February 2002

Drugs

Drug
Countries
Hong Kong, Ireland, United Kingdom